Obstructive sleep apnea (OSA) is a highly prevalent sleep disorder affecting an estimated 18 million people in the United States, and an estimated 36 million people world wide. Furthermore, the affected population is estimated to be growing at 22% per annum. OSA is not just a quality of sleep issue. OSA has several co-morbidities that drive treatment, including heart failure, hypertension, myocardial infarction, stroke, and diabetes. Despite the seriousness of the condition, it is estimated that only 5% to 8% of the affected population have been diagnosed and treated.
Approximately 80% of the patients diagnosed with OSA are prescribed continuous positive airway pressure (CPAP) therapy. Although CPAP is the first line of treatment for the majority of patients and is considered the gold-standard by most practitioners, it enjoys only 30-60% average patient compliance. Approximately 10- 15% of patients will have surgical treatment, but the surgical options tend to be invasive and are not always effective. Approximately 5- 10% of patients will use a mandibular advancement device, but such devices tend to have limited efficacy and are often associated with joint pain.
Thus, there is a need for improved OSA treatment devices in terms of patient compliance, invasiveness and efficacy.